Clearance Summary
PTS Professional Chemistry Kit received FDA 510(k) clearance under submission number K182781, sponsored by Polymer Technology Systems, Inc. D/B/A Pts Diagnostics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2018-12-21.
- Submission: K182781
- Applicant / Sponsor: Polymer Technology Systems, Inc. D/B/A Pts Diagnostics
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 2018-12-21
Classification & Regulation
This clearance is catalogued under FDA product code CGA and 21 CFR 862.1345, within the Clinical Chemistry review panel as a Class II device.